Safety and Efficacy of PG101 for Dry Eye Syndrome

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhodes Pharmaceuticals, L.P.
• Collaborator: ORA, Inc.

Criteria

Inclusion Criteria:

• Be male or female of any race, at least 18 years of age

• Have provided verbal and written informed consent

• Be able and willing to follow instructions, including participation in all study assessments and visits

• Have a reported history of dry eye syndrome

• Have a history of use or desire to use eye drops for dry eye

• If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period

• Have a best corrected visual acuity of +0.70 logMAR or better in both eyes

Exclusion Criteria:

• Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1

• Be a woman who is pregnant, nursing or planning a pregnancy

• Have a known allergy and/or sensitivity to the test article or its components

• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

• Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1